EPHA Secretariat has prepared a briefing note on the draft ’Regulation on Medicinal products for Paediatric Use’ published by the European Commission on 29 September 2004.
Extensive testing is required on all medicines authorised for use in adults to ensure they are safe, of high quality and effective. However, more than 50% of the medicines currently used to treat children have neither been tested or authorised for paediatric use.
The aim of the regulation is to improve children’s health in Europe by ensuring the authorisation of medicines that have been specifically researched and developed to meet their therapeutic needs. The briefing note outlines the key measures of the proposed regulation.
Below you can also find the position paper of the Federation of European Cancer Societies (FECS), an EPHA member.
